(154 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During deflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure.
The device is intended to be used with Omron specified cuffs as specified below
- Small 17-22cm arm cuff - circumference (PN: HEM-CS24)
- Medium 22-42cm arm cuff circumference (PN: HEM-RML31) ●
- . Extra Large (XL) cuff arm circumference 42-50cm (PN: HEM-RXL31)
The device also detects the appearance of irregular heartbeats during measurement.
The device can also send measurement data to third party applications. Transmission is via an integral FCC compliant Bluetooth Low Energy (BLE) module.
Here's an analysis of the provided text regarding the Omron Healthcare, Inc. HEM-9210T device, focusing on the acceptance criteria and the study proving its performance.
Device: Omron Healthcare, Inc. HEM-9210T (Noninvasive blood pressure measurement system)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ANSI/AAMI/ISO 81060-2) | Reported Device Performance (HEM-9210T) |
|---|---|
| Accuracy of Pressure Indicator: | Within ±3 mmHg or 2 % of reading |
| Accuracy of Pulse Rate: | Within ±5 % of reading |
Note: The document explicitly states that the device was tested for clinical accuracy in accordance with ANSI/AAMI/ISO 81060-2, and the results showed compliance to the standard. The reported performance values (±3 mmHg / 2% for pressure and ±5% for pulse rate) are consistent with the typical requirements of this standard for non-invasive blood pressure monitors.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 92 patients
- Data Provenance: Not explicitly stated, but clinical testing was performed for "clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2." This standard outlines specific requirements for patient selection and testing methodology. It's likely a prospective study, as clinical accuracy testing of this nature is generally designed prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not explicitly provided in the given document. For blood pressure clinical validation studies following ISO 81060-2, typically a minimum of three trained observers independently measure blood pressure using a mercury sphygmomanometer or validated auscultatory device. Their qualifications are usually highly specialized, often requiring certification for blood pressure measurement validation.
4. Adjudication Method for the Test Set:
- This information is not explicitly provided in the given document. In clinical validation studies of blood pressure monitors, the gold standard (ground truth) measurements taken by multiple observers are typically averaged or adjudicated through a specific protocol (e.g., if two out of three observers agree within a certain tolerance, that measurement is used; otherwise, re-measurement occurs).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers or image analysis. Therefore, an MRMC comparative effectiveness study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes. The document details "Clinical Testing Summary: Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2." This refers to the standalone performance of the device (algorithm only), comparing its measurements to a reference standard.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- The ground truth used for the clinical accuracy testing would be provided by simultaneous, independent auscultatory measurements performed by trained observers (experts) using a reference sphygmomanometer, following the strict protocols of the ANSI/AAMI/ISO 81060-2 standard. This is essentially a form of expert consensus on the "true" blood pressure measurement at the time of the device reading.
8. The Sample Size for the Training Set:
- This information is not explicitly provided in the document. The document describes clinical validation for final performance, not the internal development or training of the device's algorithms. Blood pressure monitors like this typically rely on established oscillometric principles and may be "trained" or calibrated on internal datasets during their development, but the specifics are not detailed here.
9. How the Ground Truth for the Training Set Was Established:
- This information is not explicitly provided in the document, as no specific "training set" study is detailed for this device in the public filing. If a training set were used during device development, its ground truth would likely be established through similar methods as the test set: auscultatory measurements by trained clinical personnel.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).